Surgical Green Laser System
Device Facts
| Record ID | K202828 |
|---|---|
| Device Name | Surgical Green Laser System |
| Applicant | Realton (Suzhou) Medical Technology Co., Ltd. |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | Jun 4, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The surgical green laser system is intended for surgical treatment of benign prostatic hyperplasia (BPH) through photoselective vaporization of the prostate (PVP).
Device Story
Semiconductor-pumped, Q-switched, frequency-doubled solid-state Nd:YAG green laser system (532 nm). Device delivers laser energy via fiber optic delivery device to prostate tissue for photoselective vaporization. Operated by physicians in clinical settings. System includes console, internal circulating cooling system, electronic control system, and footswitch. Output power is adjustable (up to 180W depending on model). Physician uses device to vaporize prostatic tissue, relieving BPH symptoms. Benefits include minimally invasive treatment of BPH.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including optical pulse performance, RF wireless performance, electrical safety (ANSI AAMI ES60601-1), laser safety (IEC 60825-1, IEC 60601-2-22), and electromagnetic compatibility (IEC 60601-1-2).
Technological Characteristics
Semiconductor-pumped, Q-switched, frequency-doubled solid-state Nd:YAG laser; 532 nm wavelength; 10-18 kHz pulse rate; 100-180 ns pulse width; internal circulating deionized water cooling; multimode output; 5 mW aiming beam. Standards: IEC 60825-1:2014, ANSI AAMI ES60601-1:2005/(R)2012, IEC 60601-2-22:2007, IEC 60601-1-2:2014.
Indications for Use
Indicated for surgical treatment of benign prostatic hyperplasia (BPH) in adult males via photoselective vaporization of the prostate (PVP). Contraindicated in patients with suspected prostate cancer, those unsuitable for laser surgery, critically ill patients, those where anesthesia is contraindicated, cases of calcified tissue, hemostasis of vessels >2mm, uncontrolled bleeding disorders/coagulopathy, acute urinary tract infection, or severe urethral stricture.
Regulatory Classification
Identification
(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
Predicate Devices
- GreenLight XPS Laser System (K092735)
Reference Devices
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 4, 2021
Realton (Suzhou) Medical Technology Co., Ltd. % Olivia Meng Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 8-9th Floor, R&D Building, No.26 Qinglan Street, Panyu District Guangzhou, Guangdong 510006 China
Re: K202828
Trade/Device Name: Surgical Green Laser System Regulation Number: 21 CFR§ 878.4810 Regulation Name: Laser Surgical Instrument for Use In General and Plastic Surgery and In Dermatology Regulatory Class: II Product Code: GEX Dated: April 25, 2021 Received: April 30, 2021
Dear Olivia Meng:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark J. Antonino, M.S. Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
# Indications for Use
510(k) Number (if known) K202828
Device Name Surgical Green Laser System
Indications for Use (Describe)
The surgical green laser system is intended for surgical treatment of benign prostatic hyperplasia (BPH) through photoselective vaporization of the prostate (PVP).
Type of Use (Select one or both, as applicable)
> Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for Realton Real Estate Corporation. The logo is white text on a green background. The logo includes a stylized letter R.
# 510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
- 1. SUBMITTER
Realton (Suzhou) Medical Technology Co., Ltd. 601 Room, B8 Building, 218 Xinghu Road, Suzhou Industrial Park, Suzhou, P.R.China Phone: +86-512-62868599
| Primary Contact | Olivia Meng |
|----------------------|----------------------------------------------------------------------------------------|
| Person: | Regulatory Affairs Manager |
| | Guangzhou Osmunda Medical Device Technical Service |
| | Co., Ltd. |
| | Tel: (+86)-20-6231 6262 |
| | Fax: (+86) -20-8633 0253 |
| Secondary Contact | Mingzhu Liu |
| Person: | Quality Manager |
| | Realton (Suzhou) Medical Technology Co., Ltd. |
| | Tel: (+86)-512-62868599 |
| Date prepared | May 31, 2021 |
| 2. DEVICE | |
| Device Name: | Surgical Green Laser System |
| Common/Usual Name: | Surgical Green Laser System |
| Classification Name: | Laser Surgical Instrument For Use In General And Plastic<br>Surgery And In Dermatology |
| Model: | PVP-120, PVP-140, PVP-160, PVP-180 |
| Regulation number: | 21 CFR 878.4810 |
| Regulation Class: | II |
| Product Code: | GEX Powered Laser Surgical Instrument |
- 3. PREDICATE DEVICE
GreenLight XPS Laser System (K092735)
- 4. DEVICE DESCRIPTION
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for Realton Corporation. The logo is white and is set against a green background. The logo features a stylized "R" followed by the text "EALTON" in all caps. Below the company name is the text "Realton Corporation" in a smaller font size.
The surgical green laser system is designed, manufactured by Realton (Suzhou) Medical Technology Co., Ltd.. The device is a semiconductor pumped, Q-switched and double-frequency solid-state Nd:YAG green laser. The device has the following models according to different output laser powers: PVP-120, PVP-140, PVP-160 and PVP-180. It shall be used with the laser fibers cleared under K202601.
The pulse rate of the device is 10kH-18kH, and pulse width of the device is 100ns-180ns.
#### 5. INDICATIONS FOR USE
The surgical green laser system is intended for surgical treatment of benign prostatic hyperplasia (BPH) through photo-selective vaporization of the prostate (PVP).
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for "EALTON Realtime Corporation". The logo is white text on a green background. To the left of the text is a symbol that looks like three curved lines.
#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE 6.
| | Subject device | Predicate device | Discussion of difference |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Device name | Surgical green laser system | GreenLight XPS Laser System | NA |
| K number | K202828 | K092735 | NA |
| Manufacturer | Realton (Suzhou) Medical Technology<br>Co., Ltd. | American Medical Systems, Inc. | NA |
| Indications for Use | The surgical green laser system is<br>intended for surgical treatment of<br>benign prostatic hyperplasia (BPH)<br>through photo-selective vaporization<br>of the prostate (PVP). | The GreenLight TM XPS Laser System is intended for<br>the surgical incision/excision, vaporization, ablation,<br>hemostasis and coagulation of soft tissue. All soft<br>tissue is included, such as skin, cutaneous tissue,<br>subcutaneous tissue, striated and smooth tissue,<br>muscle, cartilage meniscus, mucous membrane,<br>lymph vessels and nodes, organs and glands.<br>Suggested applications include:<br>General Surgery: Vaporizing, coagulating, incising,<br>excising, debulking, and ablating of soft tissue as<br>well as in endoscopic (e.g., laparoscopic) or open<br>surgeries.<br>Gastroenterology: Tissue ablation and hemostasis in<br>the gastrointestinal tract; esophageal neoplastic<br>obstructions, including squamous cell carcinoma and<br>adenocarcinoma; gastrointestinal<br>hemostasis<br>(including varices, espohagitis, esophageal ulcer,<br>Mallory-Weiss tear, gastric ulcer, angiodysplasia,<br>stomal ulcers, non-bleeding ulcers, gastric erosions);<br>gastrointestinal<br>tissue ablation<br>(benign<br>and<br>malignant neoplasm, angiodysplasia, polyps, ulcer, | Similar |
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for Realton Realton Corporation. The logo is white and is set against a green background. The logo features a stylized letter R and the word "REALTON" in all capital letters. Below the word "REALTON" is the phrase "Realton Corporation" in a smaller font.
| colitis, hemorrhoids). | |
|-------------------------------------------------------|--|
| Gynecology: Vaporizing, incising, or coagulating | |
| tissue associated with treatments of conditions such | |
| as: endometriosis; cervical, vulvar, and vaginal | |
| intraepithelial neoplasia; condyloma acuminata; | |
| uterine septum; intrauterine adhesions; submucosal | |
| fibroids. | |
| Head and Neck/Otorhinolaryngology (ENT): Tissue | |
| incision, excision, ablation, and vessel hemostasis. | |
| Neurosurgery: Incising, excising, coagulating, and | |
| vaporizing neurological tumors of the firm textured | |
| type. | |
| Ophthalmology:<br>Post-vitrectomy | |
| endophotocoagulation of the retina. | |
| Plastic Surgery: Vaporizing, coagulating, incising, | |
| excising, debulking, and ablating of soft tissue in | |
| endoscopic and open procedures. | |
| Spinal Surgery: Percutaneous lumbar diskectomy. | |
| Thoracic Surgery: Vaporizing, coagulating, incising, | |
| excising, debulking, and ablating of soft tissue, | |
| including lung tissue in thoroscopic or open | |
| procedures. | |
| Urology: Cutting, coagulating, or vaporizing urologic | |
| soft tissues. Open endoscopic minimally invasive | |
| urological surgery (ablation, vaporization, incision, | |
| excision and coagulation of soft tissue) including | |
| treatment of: bladder, urethral & ureteral tumors; | |
| condylomas; lesions of external genitalia; urethral & | |
| penile; hemangioma; urethral strictures; bladder | |
| | |
| neck obstructions; and vaporization of prostate | |
| tissue for men suffering from benign prostate | |
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for Ealton Real Estate Corporation. The logo is white and is set against a green background. The logo features a stylized "E" with curved lines, followed by the text "EALTON" in a bold, sans-serif font. Below the company name, in a smaller font, is the text "Real Estate Corporation."
| | hyperplasia/hypoplasia (BPH). | | |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Contraindications | | Similar | |
| | Patients who are suspected of having<br>prostate cancer or patients who are<br>not suitable for laser surgery and<br>critically ill patients in other<br>departments. Including the following<br>but not limited to:<br>The patient's medical history<br>contraindicates anesthesia Places where tissues (especially<br>tumors) are calcified For hemostasis of blood vessels<br>over 2 mm in diameter Out of control bleeding disorders<br>and coagulopathy Acute urinary tract infection Severe urethral stricture Patients with prostate cancer | The use of the Laser System is contraindicated for patients:<br>Whose general medical condition contraindicates surgical intervention Where appropriate anesthesia is contraindicated by patient history Where tissue (especially tumors) has calcified For hemostatis of vessels over approximately two millimeters in diameter Where laser therapy is not considered the treatment of choice Uncontrolled bleeding disorders and coagulopathy Prostate cancer Acute urinary tract infection (UTI) Severe urethral stricture The GreenLight XPS Laser System is contraindicated in the presence of severe urethral strictures; however, the system can be used in the treatment of urethral strictures with proper cautions. A severe stricture is any stricture with visible narrowing via urethrography or ultrasonography, with near total obstruction that makes passage of instruments difficult or dangerous. Care should be taken to avoid injury to urethral tissue. | |
| Composition | The surgical green laser system<br>consists of a semiconductor-pumped | The laser system consists of a console, which generates the green laser light and a fiber optic delivery device that transmits laser light from the | Similar |
| | | | |
| | controller, Laser internal circulating<br>cooling system, electronic control<br>system and footswitch. | console to the patient.<br>The console is a diode-pumped Solid State Laser<br>utilizing Nd:YAG laser gain medium and<br>Acousto-Optic Q Switch. | |
| Laser type | Solid state, frequency doubled,<br>Nd:YAG laser | Solid state, frequency doubled, Nd:YAG laser | Same |
| Output mode | Multimode | Multimode | Same |
| Main wavelength (nm) | 532 | 532 | Same |
| Maximum delivered<br>power | PVP-120: 120 W<br>PVP-140: 140 W<br>PVP-160: 160 W<br>PVP-180: 180 W | 180W | Similar |
| Mode of operation | Adjustable | Adjustable | Same |
| Maximum aiming beam<br>power | 5 mW | 5 mW | Same |
| Cooling type | Internal circulating | Internal circulating | Same |
| Cooling liquid | Deionized water | Distilled or deionized water | Similar |
| Operation temperature | 10° C - 30° C | 10° C - 30° C | Same |
| Relative humidity | 30%- 90% | 10%- 90% | Similar |
| Compatible device | Single-use sterile medical laser fiber<br>(model: W760SF-30, B760SF-30,<br>G760SF-30, P760SF-30, W760F-30,<br>B760FF-30, G760FF-30, P760FF-30)<br>manufactured by Realton (Suzhou)<br>Medical Technology Co., Ltd.<br>Laser protective Eyewear<br>Endoscope | GreenLight Moxy™ Fiber Optic<br>Laser protective eyewear<br>Endoscope | Similar |
| Optical operating | Pulse mode | Pulse mode | Same |
| modes | | | |
| Compatible fibers optical beam area at 2mm | 0.48mm² | 0.48mm² | Same |
| Compatible fibers applicable wavelength | 532nm | 532nm | Same |
| Compatible fibers Maximum optical transmission power | 180W | 180W | Same |
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for Realton Realton Corporation. The logo is white and is set against a green background. The logo features a stylized "R" followed by the text "EALTON" in a sans-serif font. Below the text "EALTON" is the text "Realton Corporation" in a smaller font.
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the logo for EALTON Realtime Corporation. The logo is white text on a green background. The logo consists of the word "EALTON" in large, bold letters, with the words "Realtime Corporation" in smaller letters below.
The subject device and the predicate device are similar in the indications, composition and maximum delivered power. These differences do not raise different questions of safety and effectiveness. The technological differences can be evaluated through the performance testing provided.
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image features the logo for "REALTON Real Estate Corporation". The logo is set against a green background. The word "REALTON" is prominently displayed in a sans-serif font, with a stylized graphic to the left of the text. Below "REALTON", the words "Real Estate Corporation" are written in a smaller font size.
#### SUMMARY OF TECHNOLOGICAL CHARACTERISTICS 7.
The following performance data were provided in support of the substantial equivalence determination.
### Performance testing
Performance testing was conducted on surgical green laser system according to IEC 60825-1:2014. Additionally, optical pulse and RF Wireless performance tests were conducted.
## Electrical safety, laser safety, and electromagnetic compatibility (EMC)
Electrical safety, laser safety and EMC testing were conducted on the device. The device complies with the ANSI AAMI ES60601-1:2005/(R) 2012 and A1:2012, 2012 and A2:2010/(R) 2012 (Consolidated Text), and C1:2009/(R) IEC 60601-2-22:2007(third edition) + A1:2012 for safety, and the IEC 60601-1-2:2014 standard for EMC.
### Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern.
### Clinical Testing
Based on the similarities of the device specifications, intended use, indications for use between the surgical green laser system and its predicate device, no clinical studies were needed to support this 510(k) Premarket Notification.
#### CONCLUSION 8.
The proposed device is substantially equivalent to the predicate device, GreenLight XPS Laser System, in the laser type, output mode, main wavelength, mode of operation, maximum aiming beam power, cooling type, operation temperature and relative humidity and compatible device. The non-clinical data support the safety of the device and the performance testing report demonstrate that surgical green laser system should perform as intended in the specified application conditions.
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image features the logo for "EALTON Realize Corporation". The logo is set against a green background. The word "EALTON" is prominently displayed in white, with a stylized graphic to the left of the word. Below "EALTON", the words "Realize Corporation" are written in a smaller font, also in white.
From the results of non-clinical data including the performance testing described, Realton (Suzhou) concludes that surgical green laser system is as safe and as effective as the predicate device.
